FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER— 510(k) K944790

Substantially Equivalent

Applied Medical Resources

FDA 510(k) clearance K944790 for FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER, Substantially Equivalent on 1994-11-29. Applicant: Applied Medical Resources.

Clearance details

Applicant: Applied Medical Resources
Product code: Code GBZ
Advisory panel: General, Plastic Surgery
Date received: 1994-09-28
Decision date: 1994-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, US

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Adverse events under product code GBZ

product code GBZ

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.